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The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients (VASA)

Primary Purpose

Hypertension,Essential

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sodium restriction
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension,Essential focused on measuring Salt sensitivity, Sodium sensitivity, Salt restriction, Salt-blood test, Dietary intervention, Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI ≤ 35 kg/m2
  • Essential hypertension
  • eGFR > 15 ml/min/1,73m2
  • Albumine-to-creatinine-ratio < 500 mg/g
  • Safe anticonception if women in childbearing age.
  • Able to adhere to dietary regimen

Exclusion Criteria:

  • Secondary hypertension
  • Clinically significant heart failure (NYHA 3-4)
  • Clinically significant liver disease
  • Diabetes mellitus (type 1 and 2)
  • Active cancer (except skin cancer)
  • Renal transplant
  • Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months)
  • Proliferative glomerulonephritis or ANCA-related disease
  • Continuous immunosuppressant treatment
  • Pregnancy or lactation
  • Alcohol abuse
  • If the investigator finds the participant unfit to complete the project

Sites / Locations

  • University Clinic in Nephrology and Hypertension

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sodium restriction

Usual diet

Arm Description

Outcomes

Primary Outcome Measures

Change in systolic 24-hour blood pressure
Difference in systolic blood pressure measured before and after intervention

Secondary Outcome Measures

Full Information

First Posted
December 7, 2021
Last Updated
September 21, 2023
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT05165823
Brief Title
The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients
Acronym
VASA
Official Title
The Significance of Sodium Balance for Blood Pressure in Patients With Essential Hypertension and the Value of Salt-blood Test in Identifying Salt Sensitive Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
Salt sensitivity, Sodium sensitivity, Salt restriction, Salt-blood test, Dietary intervention, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium restriction
Arm Type
Experimental
Arm Title
Usual diet
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Sodium restriction
Intervention Description
Participants will be guided in minimizing sodium intake. Guidance will be both oral and written. Bread with low sodium content will be offered to the participants.
Primary Outcome Measure Information:
Title
Change in systolic 24-hour blood pressure
Description
Difference in systolic blood pressure measured before and after intervention
Time Frame
Measured before and after 4 weeks' intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI ≤ 35 kg/m2 Essential hypertension eGFR > 15 ml/min/1,73m2 Albumine-to-creatinine-ratio < 500 mg/g Safe anticonception if women in childbearing age. Able to adhere to dietary regimen Exclusion Criteria: Secondary hypertension Clinically significant heart failure (NYHA 3-4) Clinically significant liver disease Diabetes mellitus (type 1 and 2) Active cancer (except skin cancer) Renal transplant Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months) Proliferative glomerulonephritis or ANCA-related disease Continuous immunosuppressant treatment Pregnancy or lactation Alcohol abuse If the investigator finds the participant unfit to complete the project
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Lundgreen Duus
Organizational Affiliation
University Clinic in Nephrology and Hypertension
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic in Nephrology and Hypertension
City
Herning
ZIP/Postal Code
7400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients

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